pma Primary ID: P930027

PSA IMMULITE SUBSTRATE REAGENT (UDI P930027)

Manufactured by Siemens Healthcare Diagnostics, Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The PSA IMMULITE SUBSTRATE REAGENT (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. This product is indexed under FDA Product Code / Category Classification MTF within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2703-2026 View Full Alert →

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536....

🔒 Compromised Lot & Serial Numbers Locked

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ID: Z-2398-2026 View Full Alert →

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay...

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ID: Z-1980-2026 View Full Alert →

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079....

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Technical Specifications

Model Number: N/A
Product Code / EMDN: MTF
Device Name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Database Sync Date: 2026-08-09 10:06:23

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of PSA IMMULITE SUBSTRATE REAGENT?

The registered manufacturer of record for PSA IMMULITE SUBSTRATE REAGENT is Siemens Healthcare Diagnostics, Inc..

What is the Primary UDI-DI identifier for PSA IMMULITE SUBSTRATE REAGENT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P930027.

What classification code is assigned to this device?

This device is registered under product classification code MTF.

Similar Classification Devices (MTF)

Other Devices by Siemens Healthcare Diagnostics, Inc.

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